Over 30,000 bottles of prescribed medications recalled nationwide: FDA

UNDATED (WKRC) – Thousands of cartons and bottles of cholesterol medication have been recalled nationwide.

Zydus Pharmaceuticals (USA) Inc. and AvKARE have voluntarily initiated nationwide recalls of their respective drug products due to quality concerns.

According to the U.S. Food and Drug Administration (FDA), Zydus is recalling 22,896 bottles of Icosapent Ethyl capsules, 1 gram, distributed in 120-count bottles.

The recall was initiated on Dec. 30, 2025, due to subpotency caused by oxidation from leakage, which may lead to inconsistent therapeutic effects and increased gastrointestinal side effects.

The affected lot numbers are S2520304, S2520333, and S2540186, with expiration dates in 2027.

Similarly, AvKARE is recalling Rosuvastatin Tablets, USP, 10 mg, packaged in 50-tablet unit dose cartons, according to the FDA.

The recall was initiated on Dec. 31, 2025, due to the product being out of specification for dissolution.

The affected lot number is 49124, with an expiration date of Dec. 31, 2026.

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Both recalls are ongoing, per the FDA.